HISTORY OF AMAREX
The story of Amarex Clinical Research is about its founders, Dr. Kazem Kazempour, Chief Executive Officer and Ms. Sally Breisch, Chief Operating Officer and their desire as a CRO to conduct clinical trials with ongoing innovation for improved quality and efficiency. They have developed processes and established procedures that have a direct impact on time and cost of drug and medical device development.
Prior to founding Amarex, Dr. Kazempour started his career working in the pharmaceutical industry in statistics then continued his career working for the Food & Drug Adminstration (FDA) in their Biometrics division, along with serving as an Advisory Committee Member. As a result, he developed the philosophy that successful trial management requires a partnership and collaborative effort with the FDA. Dr. Kazempour often acts as the Lead Biostatistician for all clinical trials and plays an active role in the preparation of FDA presentations.
Ms. Breisch has extensive trial experience as a former CRA, Clinical Scientist, and Associate Director of Drug Development for a global pharmaceutical company. During her time as COO, she oversaw the day-to-day operation of the company. Ms. Breisch was intimately involved with the clinical operations of every study and has put a training protocol program in place for all CRAs to follow . Dr. Kazempour and Ms. Breisch come from a diverse background in academia, industry, and the FDA; which allowed them the opportunity to provide a comprehensive approach of clinical trial management to their clients.
In their previous positions as international pharma company co-workers and Director of Biometrics and Clinical Study Directors, Dr. Kazempour and Ms. Breisch recognized many inefficiencies and deficiencies in the management and conduct of clinical trials, particularly with the services provided by CRO vendors. This led them to re-visit the clinical trial process and develop improved methods for the industry through a new CRO, Amarex Clinical Research, which was founded in 1998. What started as two people wanting better standards and providing patients access to safe and effective treatments, by knowing what needed to change in the trial process and re-creating it, The Parallel Process was developed, all on a napkin. Dr. Kazempour managed the biostatistics portion, Ms. Breisch managed the medical writing portion and both managed data management. With a lot of determination, dedication and commitment to providing safe and effective clinical products, Amarex became a Global full service Clinical Research Organization (CRO).
Their vision and goals for providing unmatached value to clients is what makes Amarex different from other CROs:
Provide very experienced leadership team members and staff for every project
Optimize time and cost while being efficient and effective with each clinical product development service
Believe in having a true collaborative partnership with our clients
Commit to a long-term client relationship and achieving the best possible outcome
Our commitment and goal with each clinical study is to be efficient and effective; so as to optimize time and cost, while still maintaining the highest level of quality and integrity in the trial.
Amarex Clinical Research has extensive experience successfully performing clinical studies from across all phases of research and discovery, development, validation and approval. We incorporate scientific excellence and product development strategy in all that we do. Our leadership team has the experience to efficiently provide solutions to the most demanding drug development challenges with a driven focus on completing projects on time, on budget and with the quality that will withstand the most vigorous scrutiny.
Our leadership team has been involved in over 400 clinical research projects in over 35 countries. Currently we are conducting studies in the United States, Canadian, our E.U. sites and through our partners in Asia. We have conducted GCP/GMP compliance audits in the EU, Israel, China, Taiwan, Korea, South America and the United States.
The leadership team has over 70 years of combined experience and expertise in conducting biomedical research, standardization of data management protocols, oversight of clinical trial operations and trial management of Phase I – IV studies of drugs, devices, botanicals, diagnostics and biologics. Their knowledge, expertise and experience in conducting comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting has enabled Amarex to take our clients through the entire process from the initial product concept to FDA approval and then ultimately to the market safely and quickly.
We recognize and understand the importance of providing leading solutions in drug and device development and we have a strong track record in advising clients through the development process. We believe in having a data-driven approach and a collaborative partnership with our clients; working closely to ensure that we provide customized solutions for your unique clinical study.
Our mission is to expedite patient access to safe and effective clinical products.
Where experience is the difference...